Rituximab Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL

  • STATUS
    Recruiting
  • End date
    Jul 25, 2025
  • participants needed
    130
  • sponsor
    Fondazione Italiana Linfomi ONLUS
Updated on 28 July 2021
cytarabine
rituximab
hepatitis b surface antigen
venetoclax
renal function tests
high dose chemotherapy
bendamustine
hepatitis b core antibody
cyclin d1

Summary

Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival.

Description

The aim of the study is to improve long term results of R-BAC, consolidating patients with high-risk (HR) features (defined as: elevated Ki67 and/or blastoid cytology and/or TP53 mutation after central pathology review) with Venetoclax (ABT-199), which has demonstrated relevant single agent activity in relapsed/refractory MCL in a Phase 1-2 trial.

The updated Progression Free Survival curves of the R-BAC500 trial has shown that the expected 2-years PFS for patients with HR disease is 40% (H0), as compared to low-risk patients (LR) that have a 2-years PFS of 100%. The addition of Venetoclax to HR patients after R-BAC is expected to improve results and efficacy of this regimen in this "difficult -to- treat" population, that represents approximately 40-45 % of newly diagnosed elderly patients with MCL. It appears reasonable to treat with the experimental drug also LR patients that do not respond appropriately (less than CR) at the end of R-BAC. Since the number of such LR patients is hardly predictable based on the present experience with R-BAC500 trial, the analysis of this sub-cohort will be of exploratory nature, and thus assessed separately.

The study objective is to evaluate whether the addition of venetoclax after R-BAC to HR patients improves the results of the standard R-BAC, in terms of Progression Free Survival .

Details
Condition Mantle cell lymphoma
Treatment venetoclax
Clinical Study IdentifierNCT03567876
SponsorFondazione Italiana Linfomi ONLUS
Last Modified on28 July 2021

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